Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-0347-2018 | Class II | Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo... | Stryker Corp. | NRY | |
| Z-1946-2018 | Class II | Syva EMIT 2000 Theophylline Product Usage: The Syva Emit 2000 Theophylline Assay is a... | Siemens Healthcare Diagnostics Inc. | KLS | |
| Z-1147-2018 | Class II | DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is... | Ethicon, Inc | OMO | |
| Z-1005-2018 | Class II | ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-1004-2018 | Class II | ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usage: The Arrow... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-1003-2018 | Class II | AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow CVC is indicated... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-1002-2018 | Class II | ARROWg+ard Blue Product Usage: The Arrow CVC is indicated to provide short-term (< 30... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-1001-2018 | Class II | ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow CVC is indicated... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-1000-2018 | Class II | ARROWg+ard Blue MAC" Two-Lumen Central Venous Access Kit Product Usage: The Arrow CVC is... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-0999-2018 | Class II | AGB+ Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow CVC is indicated... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-0998-2018 | Class II | AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow CVC is indicated... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-0997-2018 | Class II | Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-0996-2018 | Class II | Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-0995-2018 | Class II | Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-0994-2018 | Class II | Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-0342-2018 | Class II | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45... | Spineart SA | KWQ | |
| Z-0341-2018 | Class II | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45... | Spineart SA | KWQ | |
| Z-0340-2018 | Class II | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF TRY-PS-45... | Spineart SA | KWQ | |
| Z-0339-2018 | Class II | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45... | Spineart SA | KWQ | |
| Z-0338-2018 | Class II | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40... | Spineart SA | KWQ | |
| Z-0337-2018 | Class II | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40... | Spineart SA | KWQ | |
| Z-0336-2018 | Class II | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40... | Spineart SA | KWQ | |
| Z-0629-2018 | Class II | Hemotherm Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A... | Gentherm Medical, LLC | DWC | |
| Z-1129-2018 | Class II | U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The... | United Orthopedic Corp. | JWH | |
| Z-1128-2018 | Class II | U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number... | United Orthopedic Corp. | JWH | |
| Z-2333-2018 | Class III | ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1... | Microtek Medical LLC | IYO | |
| Z-2332-2018 | Class III | ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1... | Microtek Medical LLC | IYO | |
| Z-2743-2018 | Class II | Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system... | Apollo Endosurgery, Inc. | LTI | |
| Z-1271-2018 | Class II | 8F Plastic Dignity Low Profile CT Port W/Pre-Attached ChronoFlex Polyurethane Catheter | Medical Components, Inc. | LJT | |
| Z-0712-2018 | Class II | ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue... | Atrium Medical Corporation | FTL | |
| Z-0307-2018 | Class II | CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001... | Abbott Medical | FRN | |
| Z-1208-2018 | Class II | Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System... | Medtronic, Inc. | CBK | |
| Z-1149-2018 | Class II | Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash... | Medica Corp. | CHI | |
| Z-1884-2018 | Class II | Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z... | Santa Joy Ornament & Giftware Co | RDZ | |
| Z-0494-2018 | Class II | 15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400 | Horiba Instruments Incorporated | JJE | |
| Z-0493-2018 | Class II | 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400 | Horiba Instruments Incorporated | JJE | |
| Z-0635-2018 | Class II | OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and... | Oculus Optikgerate GmbH | MXK | |
| Z-1930-2019 | Class II | RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2115-2018 | Class II | Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is... | Invivo Corporation | MWI | |
| Z-1276-2018 | Class II | Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia... | Phadia AB | DHB | |
| Z-1117-2018 | Class II | Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee... | Omni Life Science, Inc. | JWH | |
| Z-0724-2018 | Class II | Integrity R1.2 | Elekta Limited | IYE | |
| Z-0723-2018 | Class II | Agility with Integrity R3.2 | Elekta Limited | IYE | |
| Z-0284-2018 | Class II | Tapered Screw-Vent MTX Model TSVTB11 | ZimVie US Corp LLC | DZE | |
| Z-1256-2020 | Class II | EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is... | EDAN Diagnostics, Inc. | MHX | |
| Z-1541-2018 | Class II | Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to... | Wallac Oy | JQP | |
| Z-0925-2018 | Class II | QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds... | Z-Medica, LLC | FRO | |
| Z-0838-2018 | Class II | ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile. | Stryker Corp. | KDD | |
| Z-0837-2018 | Class II | STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model... | Stryker Corp. | HWC | |
| Z-0836-2018 | Class II | STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a... | Stryker Corp. | GCX |